Project Description:

End Stage Renal Disease affects over 800,000 individuals in the United States necessitating the use of hemodialysis to survive. Hemodialysis patients require excessive cannulation with large gauge needles multiple times a week through vascular access sites. One of the most common of these is the arteriovenous fistula, a surgically created access site located in the arm. The excessive cannulation to this site often results in issues due to needle damage such as aneurysms and infections impacting the longevity of the lifespan of the fistula. Currently, post cannulation hemostasis is achieved by applying external pressure using gauze which is time consuming, inconsistent and does not help with the healing of the vasculature.

Our team has proposed a novel vascular sealant device, the Dialyseal, designed to stop bleeding and promote healing of arteriovenous fistulas immediately after cannulation for dialysis. The device features a sheath varying between 14-17 gauge, which houses the dialysis needle allowing dialysis to occur. After needle removal, the sheath remains at the access site where a plunger system is then used to deploy a collagen patch. The bioabsorbable collagen patch is placed externally on the vessel, covering the puncture wound and therefore sealing the vasculature in under 15 minutes. This process offers a standard approach to reduce the time for hemostasis to occur after cannulation, reduces the risk of complications associated with frequent needle punctures and overall increases the lifespan of the fistula.